TL12: Statistical Issues in the Approval of Biosimilars
View Presentation *Eric M Chi, Amgen Inc. Keywords: Draft guidances for the approval pathway of biosimilars from the FDA have been released in February 2012. The decision rules, hence statistical methods, for the approval of biosimilars are of critical importance. Statistical issues, some may be particular to biological products, for the assessment of biosimilarity will be identified and discussed.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC